Management Challenges for FY 2010

Since the implementation of PDUFA I, FDA has utilized PDUFA resources to significantly reduce the time it takes to evaluate new drugs without compromising the FDA’s rigorous standards for safety and efficacy. This has allowed the American people to gain quicker access to valuable therapies and has increased the economic incentive for sponsors to develop innovative drug and biological products. Without the funds derived from PDUFA fees, the substantial progress FDA has achieved in improving and expediting the review of human drug applications would not have been possible.

PDUFA IV enters its third year in FY 2010. Re-authorized as Title I of the Food and Drug Administration Amendments Act of 2007 (FDAAA), PDUFA IV expands user fee funding to cover post-market safety activities. FDAAA also expanded requirements under the re-authorized Pediatric Research Equity Act (Title IV) and the Best Pharmaceuticals for Children Act (Title V). In addition, FDAAA Title IX gave FDA substantially expanded responsibilities and authorities regarding the post-market safety of drugs. For example, FDA can now require risk evaluation and mitigation strategies for approved drug products, require sponsors to conduct post-market studies and clinical trials, and require safety labeling changes to address new safety information for marketed drugs. FDA is also tasked with developing systems capable of performing active post-market risk identification and analysis. These new provisions greatly strengthen FDA’s ability to perform its mission of ensuring the availability of safe and effective drugs and biologics, but they also place increasing workload demands on FDA. The added responsibilities of FDAAA Titles IV, V and IX pertaining to new drugs and biologics are now part of the process for the review of human drugs, and some of these additional technically challenging tasks must be conducted within the already existing review timeframes.

In addition to the statutory changes, the human drug review process is impacted by changes in industry operations that affect the content of NDA and BLA review. These include trends toward increasing numbers of distant, foreign-based clinical trials included in marketing applications, and similar trends in the drug manufacturing facilities named in marketing applications. FDA must plan for the time required to travel to these sites, as well as to conduct these inspections, within the same time frames that were established over a decade ago before manufacturing and clinical trials increasingly shifted to sites overseas.

Effective Information Management (IM) has become a critical element of FDA’s strategy to address the challenges of new legislative mandates and industry shifts to multi-site worldwide operations. This requires building a modern, stable, and secure Information Technology (IT) infrastructure. As one component of this effort, FDA is in the process of migrating its servers to two consolidated data centers, one of which is located at the White Oak Campus in Silver Spring, Maryland. IT/IM costs represent a significant and growing component of PDUFA spending. For example, system security costs have been increasing with the growing presence and sophistication of cyber threats. In general, successful IT/IM investment and operations will require continuing focused oversight and strong technical, business, and contract management throughout the entire IT/IM system lifecycle. In addition, to take full advantage of the increasingly electronic format of submitted applications, the agency is also taking steps to help ensure that data can be submitted in a standardized form that can be more easily accessed and analyzed by agency reviewers. IT/IM improvements are also needed to ensure that FDA can meet the timelines agreed to under PDUFA and implement drug safety requirements of FDAAA Title IX.

In addition, in FY 2010 FDA will have to initiate the steps required in FDAAA for the reauthorization of PDUFA, since the current authorization expires at the end of FY 2012.

PDUFA funding will continue to ensure that FDA rises to the challenge to meet the evolving demands of protecting the public health and the realities of the global situation.